Sinoxal 50 mg prašak za otopinu za infuziju; Sinoxal 100 mg prašak za otopinu za infuziju
| Name | Sinoxal 50 mg prašak za otopinu za infuziju; Sinoxal 100 mg prašak za otopinu za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-640588353 |
| Active Substance | oksaliplatin |
| Composition | 1 ml rekonstituirane otopine za infuziju sadrži 5 mg oksaliplatina |
| Pharmaceutical Form | prašak za otopinu za infuziju |
| Manufacturer | Actavis Italy S.p.A. - Nerviano Plant, Nerviano (Milan), Italija;
S.C. Sindan-Pharma S.R.L., Bukurešt, Rumunjska |
| Marketing Authorisation Holder | Actavis Group PTC ehf, Reykjavikurvegur 76-78, Hafnarfjordur, Island |
| Marketing Authorisation Date | 30.09.2015 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/14-02/401 |
| Registration Number | 381-12-01/70-15-11 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L01XA03 |
| Medicinal product marketed in the Croatia | Trajni prekid opskrbe |
| SmPC | download |
| PL | download |
